CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,061 enrolled
Drug / intervention
Tigecycline +1 moredrug
Likely dose
Tigecycline 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00366249
NCT00366249Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Comparison Study of the Safety and Efficacy of a Once-Daily Dose of Tigecycline Versus Ertapenem for the Treatment of Foot Infections in Subjects With Diabetes

Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Aug 21, 2006·Updated Apr 28, 2010

In Brief

A Phase 3 clinical trial evaluating Tigecycline and Ertapenem for Bacterial Infections and 2 related conditions. Completed, enrolled 1,061 participants across 211 sites in 39 countries.

Detailed Summary

The purpose of this study was to look at the safety and effectiveness of a once-daily dose of tigecycline compared to ertapenem for the treatment of diabetic foot infections. The co-primary efficacy endpoints were not met.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBacterial Infections, Diabetic Foot, Osteomyelitis
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Italy, Latvia, Lithuania, Mexico, Panama, Peru, Poland, Portugal, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 21, 2006
Enrollment StartJan 1, 2007
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 19.9 years ago

Interventions

Tigecyclinedrug

150 mg Tigecycline once-daily IV infusion for up to 28 days, or 42 days for the substudy wth osteomyelitis

Ertapenemdrug

Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).